(116 days)
Not Found
No
The description focuses on mechanical components and their function in laparoscopic procedures, with no mention of AI/ML or related concepts like image processing, data analysis, or algorithms.
No.
The device is described as a Port Access System used in laparoscopic procedures to provide access to surgical sites, acting as a channel for instruments. It does not perform a therapeutic function itself.
No
The device description indicates that the Port Access System is used to provide access to surgical sites during laparoscopic procedures and acts as a channel for instruments. It does not mention any function related to diagnosing medical conditions.
No
The device description explicitly states that the Port Access System consists of reusable and single-use components, including trocars and cannulas, which are physical hardware components used in laparoscopic procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "laparoscopic procedures to the abdominal and thoracic cavities while maintaining pneumoperitoneum." This describes a surgical tool used in vivo (within the body) to facilitate surgical access.
- Device Description: The description details a system for creating and maintaining access ports during surgery, allowing for the introduction of instruments and endoscopes. This is a surgical access device, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are typically used to diagnose diseases, monitor conditions, or screen for specific markers by testing samples.
Therefore, the Port Access System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Port Access System is indicated for use in laparoscopic procedures to the abdominal and thoracic cavities while maintaining pneumoperitoneum.
The Port Access System is indicated for use in laparoscopic procedures to give access to the abdominal and thoracic cavities while maintaining pneumoperitoneum.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Port Access System consists of reusable and single use components sold in various configurations. The ports accommodate laparoscopic instrument diameters from 5mm up to the diameter indicated on the chosen accompanying cannula. All single use parts are sterlised using gamma irradiation and supplied to the customer in a sterile condition.
In order to obtain access to the surgical site during laparoscopic surgery, the trocar is introduced into the cannula to accomplish cannula penetration of the abdominal wall. The cannula is connected to the single use seal at its proximal end and once the abdominal/thoracic wall is punctured, the trocar is removed. The cannula acts as a channel for the introduction of the endoscopes and instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal and thoracic cavities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A comparative review of the Port Access System with the predicate devices was conducted and the following performance data are provided in support of determining substantial equivalence of Port Access System to the predicate devices.
Biocompatibility: Biological evaluation of the single use and reusable components of the Port Access System was conducted in accordance with International Standard ISO 10993-1:2018 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process and the US FDA quidance document Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process' (2016 & 2020).
Non-Clinical Testing: The Port Access System was evaluated for its safety and effectiveness based on the following testing: Sealing Performance, Instrument Insertion Force (Universal Seal), Instrument Shaft Friction (Universal Seal), Instrument Compatibility (Universal Seal), Seal Contamination, Insertion Force, Insufflation, Seal Core Inversion Testing, Tensile, Torque, Endoscope Insertion/Retraction, Fatigue, Shelf Life, Transit studies, Cleaning & Sterilisation Validation, Usability.
Clinical Studies: No Clinical Studies were conducted as part of this submission. Non-Clinical Testing was sufficient to demonstrate substantial equivalence to the predicate device.
Conclusion: The information presented in the 510(k) premarket notifications demonstrates that the Port Access System is considered substantially equivalent to the predicate device. The Non-Clinical Bench Testing performed demonstrates that the Port Access System is safe, effective and performs within its design specifications and is substantially equivalent to the predicate devices. The Port Access System is as safe and effective as the currently marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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June 18, 2021
Surgical Innovations Limited Stephen Seed Compliance Director Clayton Wood House, 6 Clayton Wood Bank Leeds, West Yorkshire LS16 6OZ United Kingdom
Re: K210495
Trade/Device Name: Port Access System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: May 27, 2021 Received: June 1, 2021
Dear Stephen Seed:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long H. Chen. Ph.D. Assistant Director Non-Light Based Energy Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210495
Device Name Port Access System
Indications for Use (Describe)
The Port Access System is indicated for use in laparoscopic procedures to the abdominal and thoracic cavities while maintaining pneumoperitoneum.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 201.5 Subject to Rx) |
|---|
| ☐ Over-The-Counter Use (21 CFR 201.5 Subject to OTC) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Surgical Innovations. The word "Surgical" is in a teal color, and the word "Innovations" is in a gray color. The logo is simple and modern.
Port Access System Section 5: 510(k) Summary
-Submitter
Surgical Innovations Limited Clayton Wood House 6 Clayton Wood Bank Leeds LS16 6QZ United Kingdom
Phone: +44 (0) 113 230 7597
Contact Person: Stephen Seed Date Prepared: 25 March 2021
II. Device
Name of Device: Port Access System Common Name: Laparoscopic Port System Classification Name: Endoscope and Accessories (21 CFR 876.1500) Requlatory Class: II Product Code: GCJ
lll. Predicate Device
YelloPort Elite Port Access System - K190592
The predicate has not been subject to any design-related recalls.
IV. Device Description
The Port Access System consists of reusable and single use components sold in various configurations. The ports accommodate laparoscopic instrument diameters from 5mm up to the diameter indicated on the chosen accompanying cannula. All single use parts are sterlised using gamma irradiation and supplied to the customer in a sterile condition.
In order to obtain access to the surgical site during laparoscopic surgery, the trocar is introduced into the cannula to accomplish cannula penetration of the abdominal wall. The cannula is connected to the single use seal at its proximal end and once the abdominal/thoracic wall is punctured, the trocar is removed. The cannula acts as a channel for the introduction of the endoscopes and instruments.
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Image /page/4/Picture/1 description: The image contains the logo for Surgical Innovations. The word "Surgical" is in a teal color, and the word "Innovations" is in a gray color. The logo is simple and modern.
V. Indications for Use
The Port Access System is indicated for use in laparoscopic procedures to give access to the abdominal and thoracic cavities while maintaining pneumoperitoneum.
VI. Comparison of Technological Characteristics with the Predicate Device
| Property | Proposed Device | Primary Predicate |
|---|---|---|
| Common Name | Port Access System | |
| Laparoscope, General & Plastic | ||
| Surgery | YelloPort Elite Port Access System | |
| Laparoscope, General & Plastic | ||
| Surgery | ||
| Device Manufacturer | Surgical Innovations | Surgical Innovations |
| Device Classification | II | II |
| Primary Product Code | GCJ | GCJ |
| 510(k) Number | N/A | K190592 |
| Environment | Hospital | Hospital |
| Intended Use/ Indication for Use | The Port Access System is indicated | |
| for use in laparoscopic procedures to | ||
| give access to the abdominal and | ||
| thoracic cavities while maintaining | ||
| pneumoperitoneum. | The YelloPort Elite Port Access | |
| System is indicated for use in | ||
| laparoscopic procedures to give | ||
| access to the abdominal cavity while | ||
| maintaining pneumoperitoneum. | ||
| The YelloPort Elite Port access | ||
| system is also indicated for use in | ||
| laparoscopic procedures to give | ||
| access to the thoracic cavity. | ||
| Trocar Tip Geometries | Bladeless, Pencil point, Locking | |
| Shielded, Quill | Blunt, Pencil point, Pyramidal, | |
| Shielded (locking) | ||
| Trocar / Cannula Diameter and | ||
| Lengths | Available in 5, 10 and 12 mm | |
| diameters; and in 55, 70, 95, and 105 | ||
| and 150 mm working lengths. | Available in 10 and 12 mm diameter; | |
| and in 75, 105 and 150 mm working | ||
| lengths. | ||
| Comparison of Use: | Allows instruments from 5mm -12mm | |
| in diameter to be used. | Allows instruments from 5mm -12mm | |
| in diameter to be used. | ||
| Trocar Patient Contacting Material | Single Use: Copolyester | |
| Reusable: Stainless Steel | Stainless Steel | |
| Trocar Supplied: | Single Use: Sterile | |
| Reusable: Non-Sterile | Non-sterile (Reusable) | |
| Cannula Patient Contacting | ||
| Materials | Single Use: Copolyester | |
| Reusable: PEEK plastic | PEEK plastic | |
| Cannula Supplied: | Single Use: Sterile | |
| Reusable: Non-Sterile | Non-sterile (Reusable) | |
| Seal | Consists of: | |
| Non-Return Valve & | ||
| Instrument Seal | Consists of: | |
| Non-Return Valve & | ||
| Instrument Seal | ||
| Seal Supplied: | Sterile | Sterile |
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Image /page/5/Picture/1 description: The image contains the logo for Surgical Innovations. The word "Surgical" is in teal, and the word "Innovations" is in gray. The logo is simple and modern.
VII. Performance Data
A comparative review of the Port Access System with the predicate devices was conducted and the following performance data are provided in support of determining substantial equivalence of Port Access System to the predicate devices.
Biocompatibility
Biological evaluation of the single use and reusable components of the Port Access System was conducted in accordance with International Standard ISO 10993-1:2018 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process and the US FDA quidance document Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process' (2016 & 2020).
Non-Clinical Testing
The Port Access System was evaluated for its safety and effectiveness based on the following testing:
- Sealing Performance ●
- Instrument Insertion Force (Universal Seal)
- Instrument Shaft Friction (Universal Seal)
- . Instrument Compatibility (Universal Seal)
- Seal Contamination
- Insertion Force
- . Insufflation
- . Seal Core Inversion Testing
- Tensile ●
- . Torque
- Endoscope Insertion/Retraction
- . Fatigue
- Shelf Life
- Transit studies
- . Cleaning & Sterilisation Validation
- . Usability
Clinical Studies
No Clinical Studies were conducted as part of this submission. Non-Clinical Testing was sufficient to demonstrate substantial equivalence to the predicate device.
VIII. Conclusions
The information presented in the 510(k) premarket notifications demonstrates that the Port Access System is considered substantially equivalent to the predicate device. The Non-Clinical Bench Testing performed demonstrates that the Port Access System is safe, effective and performs within its design specifications and is substantially equivalent to the predicate devices. The Port Access System is as safe and effective as the currently marketed predicate devices.